KDMF (Korea Drug Master File) Approved Products & Companies

Sam-O Pharmaceutical Co., Ltd.

  • Product:

    Carvedilol

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-60-B-157-09

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Sam-O Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    Spain

  • Status:

    Active

  • Manufacturer:

    Corprima SA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    Pablo Picasso, 1508213 Polinya (Barcelona)Spain

Sama Pharmaceutical Co., Ltd.

  • Product:

    Clarithromycin

  • Initial Registration:

    2011-04-14

  • Registration Number:

    20050915-62-A-169-09(5)

  • MFDS Classification:

    etc

  • Applicant:

    Sama Pharmaceutical Co., Ltd.

  • Last Modified:

    2024-02-06

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Ind-swift Laboratories Limitde

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    Village Bhagwanpur, Barwala Road, Derabassi, District - SAS Nagar (Mohali) Punjab, India

Samchundang Pharmaceutical Co., Ltd.

  • Product:

    Clarithromycin

  • Initial Registration:

    2011-04-14

  • Registration Number:

    20050915-62-A-169-09(3)

  • MFDS Classification:

    etc

  • Applicant:

    Samchundang Pharmaceutical Co., Ltd.

  • Last Modified:

    2017-08-03

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Ind-Swift Laboratories Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    Village Bhagwanpur, Barwala Road, Derabassi, District-SAS Nagar (Mohali) Punjab, India

Samhwa Biopharm Co., Ltd.

  • Product:

    Topiso Farm

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-64-C-190-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Samhwa Biopharm Co., Ltd.

  • Last Modified:

    2014-10-02

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Samhwa Biopharm Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    150 Hyeopnyeop-ro, Siheung-si, Gyeonggi-do

Samik Pharmaceutical Co., Ltd.

  • Product:

    losartan potassium

  • Initial Registration:

    2011-04-14

  • Registration Number:

    20100226-122-G-72-17(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Samik Pharmaceutical Co., Ltd.

  • Last Modified:

    2021-11-10

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Huahai Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Chuannan, Duqiao, Linhai, Zhejiang

Samil Pharmaceutical Co., Ltd.

  • Product:

    Ondansetron hydrochloride hydrate

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-47-B-119(1)-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Samil Pharmaceutical Co., Ltd.

  • Last Modified:

    2023-07-31

  • Country:

    Singapore

  • Status:

    Active

  • Manufacturer:

    Glaxo Wellcome Manufacturing Pte Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    1 Pioneer Sector 1, Singapore 628413

Samjin Pharmaceutical Co., Ltd.

  • Product:

    Amoxicillin sodium

  • Initial Registration:

    2011-12-15

  • Registration Number:

    20110916-30-A-249-17(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Samjin Pharmaceutical Co., Ltd.

  • Last Modified:

    2023-03-15

  • Country:

    Spain

  • Status:

    Active

  • Manufacturer:

    Sandoz Industrial Product, SA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    c/Gorg del Moli d'En Puigverd, 37-41 E-08389 Palafolls, Barcelona, SPAIN

Samnam Pharmaceutical Co., Ltd.

  • Product:

    Levothyroxine sodium hydrate

  • Initial Registration:

    2020-01-10

  • Registration Number:

    20181023-209-J-104(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Samnam Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    germany

  • Status:

    Active

  • Manufacturer:

    Peptido GmbH

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Am Kraftwerk 6, 66450 Bexbach, Germany

Sampung Finechem Co., Ltd.

  • Product:

    Dienogest

  • Initial Registration:

    2020-02-13

  • Registration Number:

    Su437-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Sampung Finechem Co., Ltd.

  • Last Modified:

    2025-03-26

  • Country:

  • Status:

    Active

  • Manufacturer:

    Newchem SpA@[Microp Manufacturing Plant]Microchem SRL

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    Via Roveggia, 47-37136 Verona, Italy.@[Micronising Factory]Via Turati, 2-29017 Fiorenzuola D'arda (PC), Italy

Sampung Pharmachem Co., Ltd.

  • Product:

    Cefaclor hydrate

  • Initial Registration:

    2012-03-23

  • Registration Number:

    20050831-20-A-21-05(B)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Sampung Pharmachem Co., Ltd.

  • Last Modified:

    2024-10-21

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    LUPIN LTD

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Unit-1, 198-202, New industrial area no.2 Dist. - Raisen mandideep Madhya Pradesh 462046, India

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